A Comparative, Retrospective Chart Review of Intended Dwell Time of a PICC Line

May 25, 2021 updated by: Access Vascular Inc
This is a retrospective, matched pair comparative post market review of 4Fr Single Lumen PICC lines. The subjects will be matched by the timeframe of when the HydroPICCs were inserted.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects would have received a 4 Fr Single Lumen PICC line between Aug 2020 and Oct 2020.

The two groups will be HydroPICCs and the standard of care for the facility.

A comparison of multiple endpoints will be evaluated between the two groups.

Study Type

Observational

Enrollment (Actual)

121

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Romeoville, Illinois, United States, 60446
        • Joseph Bunch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any patients at the study site that received a 4 Fr single lumen PICC line from Aug 2020 through Oct 2020.

Description

Inclusion Criteria:

  • Subjects who have been inserted with the HydroPICC during a specific time range.
  • During the same time period, any competitor 4 Fr single lumen placed.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HydroPICC
Cohort who received the HydroPICC
Device: HydroPICC
PICC lines
Other Names:
  • Standard of Care
Standard of Care
Cohort who received something different than HydroPICC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intended dwell time based on a comparison of the actual dwell time to the intended time
Time Frame: August 2020 through October 2020
Comparison of actual vs intended dwell times of each arm
August 2020 through October 2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of failure rates
Time Frame: August 2020 through October 2020
Compare the failure rates between the two arms
August 2020 through October 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Access Vascular Inc

Investigators

  • Principal Investigator: Joseph Bunch, ProVasc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 13, 2020

Primary Completion (ACTUAL)

April 23, 2021

Study Completion (ACTUAL)

April 23, 2021

Study Registration Dates

First Submitted

December 1, 2020

First Submitted That Met QC Criteria

December 1, 2020

First Posted (ACTUAL)

December 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 26, 2021

Last Update Submitted That Met QC Criteria

May 25, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • CLIN 20-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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